Ventilator-induced Lung InjuryNCT05859906
The Effect of Two Different Intra-abdominal Pressure Applications on "Mechanical Power" in Laparoscopic Cholecystectomy
An observational study of Ventilator-induced Lung Injury, run by Ayse Ulgey at 1 site in Turkey (Türkiye).
Trial summary
In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventilator-induced Lung Injury
- What is being tested?
- mechanical power measurement
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Oct 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients who will be operated for laparoscopic cholecystectomy at Erciyes University between May 2023 and Oct 2023 will be included in our study.
Who may be able to join
- Patients with ASA 1-2
- The patient's willingness to participate in the study voluntarily
Who cannot join
- Patients with ASA 3-4
- Patients with lung disease such as pneumonia, COPD attack before the operation
- Patients undergoing other surgical procedures or anesthesia technique
- Pregnant patients
- Patients with morbid obesity
- Unstable patients such as uncontrolled hypertension, decompensated heart disease
- The patient's intraoperative intra-abdominal pressure value is operated with a difference from the pressure determined due to optimal surgical conditions or the patient's lungs do not tolerate it, or switching to open surgery (laparotomy) for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Two Different Intra-abdominal Pressure Applications on "Mechanical Power" in Cases Undergoing Laparoscopic Cholecystectomy
In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Laparoscopic cholecystectomy operation is routinely performed with 12 mmHg and 14 mmHg pressures in our operating room, and the preferred pressure value is; It is determined by the surgical team to be the most appropriate value for the patient and the operation. Both pressure values applied to the patients intraoperatively are within safe ranges.
The mechanical power of ventilation (MP) is the amount of energy transferred per unit time from the mechanical ventilator to the respiratory system. Although this energy is mainly used to overcome airway resistance, some of it directly affects the lung tissue, potentially causing ventilator induced lung injury (VILI). To prevent ventilator-associated lung injury, it requires the mechanical ventilator to be adjusted so that the least amount of energy is transferred to the respiratory system per unit time for each patient. In the results obtained in the published studies; increased mechanical strength has been associated with increased in-hospital mortality, higher hospital stay and higher ICU follow-up requirement.
The aim of this study is to investigate the effect of two different intra-operative intra-abdominal pressure levels applied to patients who underwent laparoscopic cholecystectomy under general anesthesia on 'Mechanical Power (MP)'.
Read the detailed description
In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Intra-abdominal pressure is continuously measured by pressure monitoring, which is routinely performed during laparoscopic procedures. The applied intra-abdominal pressure is determined by the surgical team and the most optimal value that creates pneumoperitoneum for the patient is preferred. Abdominal compartment syndrome can be seen due to abdominal hypertension at intra-abdominal pressure values above 20 mmHg.
Both pressure values aimed to be applied in this study are applied in laparoscopic cholecystectomy operations and do not cause any harm to the patient and their superiority to each other has not been determined.
Laparoscopic cholecystectomy operation is routinely performed with 12 mmHg or 14 mmHg pressures in our operating room. Both pressure values applied to the patients intraoperatively are within safe ranges.
The mechanical power of ventilation (MP) is the amount of energy transferred per unit time from the mechanical ventilator to the respiratory system. Although this energy is mainly used to overcome airway resistance and respiratory system compliance, some of it directly affects the lung tissue, potentially causing ventilator induced lung injury (VILI).
MP is a summary variable that includes several components, including tidal volume (VT ), peak pressure (Ppeak), driving pressure (Driving Pressure, ΔP), and respiratory rate (RR). These components; requires that the mechanical ventilator be adjusted so that the least amount of energy is transferred to the respiratory system per unit time for each patient in order to prevent ventilator-associated lung injury.
In the researches; a relationship between mechanical power (MP) and complications such as ventilator-associated lung injury (VILI) and acute respiratory distress syndrome (ARDS) has been found. The findings suggest that the mechanical force applied to the lungs should be reduced during intraoperative ventilation in patients undergoing major surgery. In adult patients undergoing general anesthesia during major surgical operations, higher patient exposure to ventilation as measured by higher mechanical power; it has been shown that it is associated with an increased risk of postoperative pulmonary complications and acute respiratory failure in the first 7 days of the postoperative period.
In the results obtained in the published studies; increased mechanical strength has been associated with increased in-hospital mortality and higher hospital stay and higher ICU follow-up requirement.
The aim of this study is to investigate the effect of two different intra-operative intra-abdominal pressure levels applied to patients who underwent laparoscopic cholecystectomy under general anesthesia on 'Mechanical Power (MP)'.
- Conditions
- Ventilator-induced Lung Injury
- Being tested
- mechanical power measurement
- Keywords
- Mechanical power, laparoscopic surgery, Ventilator-induced lung injury
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical power measurementOther
Mechanical power values of the patients;
- Before insufflation (baseline value),
- 0 min after insufflation,
- 15th min after insufflation,
- 30 minutes after insufflation,
- 45th minute after insufflation (if insufflation continues),
- 60th minute after insufflation (if insufflation continues),
- Intraoperative after insufflation It will be measured with the following formula in the specified periods. MP = 0.098 x minute ventilation x [Peak inspiratory pressure - 0.5 x (Plateau pressure - Positive end-expiratory pressure)]
| Study group | Role | What they receive |
|---|---|---|
| Group 12 mmHg | All patients in this group will be operated with an insufflation pressure of 12 mmHg during laparoscopic cholecystectomy surgery. Receives: Other: mechanical power measurement | |
| Group 14 mmHg | All patients in this group will be operated with an insufflation pressure of 14 mmHg during laparoscopic cholecystectomy surgery. Receives: Other: mechanical power measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-induced lung injury (barotrauma)
mechanical power values measured during operation will be recorded
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 May 2023 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator-induced Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ayse Ulgey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayse Ulgey, TC Erciyes University
- Investigators
- Ayşe Ülgey, MD, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859906
- Sponsor's protocol ID
- 2023/104
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identifed individual participant data for all primary and secondary outcome measures will be made available.
Publications
Protti A, Andreis DT, Monti M, Santini A, Sparacino CC, Langer T, Votta E, Gatti S, Lombardi L, Leopardi O, Masson S, Cressoni M, Gattinoni L. Lung stress and strain during mechanical ventilation: any difference between statics and dynamics? Crit Care Med. 2013 Apr;41(4):1046-55. doi: 10.1097/CCM.0b013e31827417a6.
PubMed 23385096Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
PubMed 26872367Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Karalapillai D, Weinberg L, Neto A S, Peyton P, Ellard L, Hu R, Pearce B, Tan CO, Story D, O'Donnell M, Hamilton P, Oughton C, Galtieri J, Wilson A, Eastwood G, Bellomo R, Jones DA. Intra-operative ventilator mechanical power as a predictor of postoperative pulmonary complications in surgical patients: A secondary analysis of a randomised clinical trial. Eur J Anaesthesiol. 2022 Jan 1;39(1):67-74. doi: 10.1097/EJA.0000000000001601.
PubMed 34560687
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Two Different Intra-abdominal Pressure Applications on "Mechanical Power" in Cases Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05859906
- Acronym / sponsor ID
- 2023/104
- Conditions
- Ventilator-induced Lung Injury
- Keywords
- Mechanical power, laparoscopic surgery, Ventilator-induced lung injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ayse UlgeyUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Laparoscopic cholecystectomy operation is routinely performed with 12 mmHg and 14 mmHg pressures in our operating room, and the preferred pressure value is; It is determined by the surgical team to be the most appropriate value for the patient and the operation. Both pressure values applied to the patients intraoperatively are within safe ranges.
The mechanical power of ventilation (MP) is the amount of energy transferred per unit time from the mechanical ventilator to the respiratory system. Although this energy is mainly used to overcome airway resistance, some of it directly affects the lung tissue, potentially causing ventilator induced lung injury (VILI). To prevent ventilator-associated lung injury, it requires the mechanical ventilator to be adjusted so that the least amount of energy is transferred to the respiratory system per unit time for each patient. In the results obtained in the published studies; increased mechanical strength has been associated with increased in-hospital mortality, higher hospital stay and higher ICU follow-up requirement.
The aim of this study is to investigate the effect of two different intra-operative intra-abdominal pressure levels applied to patients who underwent laparoscopic cholecystectomy under general anesthesia on 'Mechanical Power (MP)'.
Detailed description
In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Intra-abdominal pressure is continuously measured by pressure monitoring, which is routinely performed during laparoscopic procedures. The applied intra-abdominal pressure is determined by the surgical team and the most optimal value that creates pneumoperitoneum for the patient is preferred. Abdominal compartment syndrome can be seen due to abdominal hypertension at intra-abdominal pressure values above 20 mmHg.
Both pressure values aimed to be applied in this study are applied in laparoscopic cholecystectomy operations and do not cause any harm to the patient and their superiority to each other has not been determined.
Laparoscopic cholecystectomy operation is routinely performed with 12 mmHg or 14 mmHg pressures in our operating room. Both pressure values applied to the patients intraoperatively are within safe ranges.
The mechanical power of ventilation (MP) is the amount of energy transferred per unit time from the mechanical ventilator to the respiratory system. Although this energy is mainly used to overcome airway resistance and respiratory system compliance, some of it directly affects the lung tissue, potentially causing ventilator induced lung injury (VILI).
MP is a summary variable that includes several components, including tidal volume (VT ), peak pressure (Ppeak), driving pressure (Driving Pressure, ΔP), and respiratory rate (RR). These components; requires that the mechanical ventilator be adjusted so that the least amount of energy is transferred to the respiratory system per unit time for each patient in order to prevent ventilator-associated lung injury.
In the researches; a relationship between mechanical power (MP) and complications such as ventilator-associated lung injury (VILI) and acute respiratory distress syndrome (ARDS) has been found. The findings suggest that the mechanical force applied to the lungs should be reduced during intraoperative ventilation in patients undergoing major surgery. In adult patients undergoing general anesthesia during major surgical operations, higher patient exposure to ventilation as measured by higher mechanical power; it has been shown that it is associated with an increased risk of postoperative pulmonary complications and acute respiratory failure in the first 7 days of the postoperative period.
In the results obtained in the published studies; increased mechanical strength has been associated with increased in-hospital mortality and higher hospital stay and higher ICU follow-up requirement.
The aim of this study is to investigate the effect of two different intra-operative intra-abdominal pressure levels applied to patients who underwent laparoscopic cholecystectomy under general anesthesia on 'Mechanical Power (MP)'.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 12 mmHg | – | Other: mechanical power measurementAll patients in this group will be operated with an insufflation pressure of 12 mmHg during laparoscopic cholecystectomy surgery. |
| Group 14 mmHg | – | Other: mechanical power measurementAll patients in this group will be operated with an insufflation pressure of 14 mmHg during laparoscopic cholecystectomy surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients who will be operated for laparoscopic cholecystectomy at Erciyes University between May 2023 and Oct 2023 will be included in our study.
Key inclusion criteria (2 listed)
- Patients with ASA 1-2
- The patient's willingness to participate in the study voluntarily
Key exclusion criteria (7 listed)
- Patients with ASA 3-4
- Patients with lung disease such as pneumonia, COPD attack before the operation
- Patients undergoing other surgical procedures or anesthesia technique
- Pregnant patients
- Patients with morbid obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical power measurementMechanical power values of the patients; * Before insufflation (baseline value), * 0 min after insufflation, * 15th min after insufflation, * 30 minutes after insufflation, * 45th minute after insufflation (if insufflation continues), * 60th minute after insufflation (if insufflation continues), * Intraoperative after insufflation It will be measured with the following formula in the specified periods. MP = 0.098 x minute ventilation x [Peak inspiratory pressure - 0.5 x (Plateau pressure - Positive end-expiratory pressure)] | Other | Group 12 mmHg, Group 14 mmHg |
Primary outcome
ventilator-induced lung injury (barotrauma)
Time frame: during the operation
mechanical power values measured during operation will be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 23385096Protti A, Andreis DT, Monti M, Santini A, Sparacino CC, Langer T, Votta E, Gatti S, Lombardi L, Leopardi O, Masson S, Cressoni M, Gattinoni L. Lung stress and strain during mechanical ventilation: any difference between statics and dynamics? Crit Care Med. 2013 Apr;41(4):1046-55. doi: 10.1097/CCM.0b013e31827417a6.
- Background: PubMed 26872367Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Background: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 34560687Karalapillai D, Weinberg L, Neto A S, Peyton P, Ellard L, Hu R, Pearce B, Tan CO, Story D, O'Donnell M, Hamilton P, Oughton C, Galtieri J, Wilson A, Eastwood G, Bellomo R, Jones DA. Intra-operative ventilator mechanical power as a predictor of postoperative pulmonary complications in surgical patients: A secondary analysis of a randomised clinical trial. Eur J Anaesthesiol. 2022 Jan 1;39(1):67-74. doi: 10.1097/EJA.0000000000001601.
- Individual participant dataSharing planned: Yes. De-identifed individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Ülgey, MD study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-induced Lung Injury, run by Ayse Ulgey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Ülgey, MD (05378201751, aulgey@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator-induced lung injury (barotrauma) (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859906, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.